Lead Mobilization & Bone Turnover in Pregnancy/Lactation

This study has been completed.
Sponsor:
Information provided by:
National Institute of Environmental Health Sciences (NIEHS)
ClinicalTrials.gov Identifier:
NCT00011726
First received: February 27, 2001
Last updated: March 22, 2006
Last verified: March 2006
  Purpose

We are examining the role of maternal bone lead turnover during pregnancy and lactation as a potential source of lead exposure for the fetus and the infant (via breast milk). A cohort, ascertained at entry to care, consists of >1000 women to be followed through pregnancy. In the postpartum subjects are recruited for a nested case control study to assess the influence of lactation on maternal bone density, maternal blood lead and breast milk lead.


Condition
Lead Poisoning

Study Type: Observational
Study Design: Observational Model: Natural History
Time Perspective: Longitudinal

Resource links provided by NLM:


Further study details as provided by National Institute of Environmental Health Sciences (NIEHS):

Estimated Enrollment: 1000
Study Start Date: August 1996
Estimated Study Completion Date: December 2002
  Eligibility

Ages Eligible for Study:   12 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria
  1. Positive pregnancy test, age 12-35 and informed consent;
  2. Gestation <28 weeks at entry to prenatal care;
  3. No history of serious chronic or metabolic diseases, which could affect maternal growth or bone density;
  4. Not corticosteroid user or diagnosed use of illicit drugs;
  5. Eligible for lactation study: Ascertainment during or participation in the pregnancy study and a negative pregnancy test.
  Contacts and Locations
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No Contacts or Locations Provided
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00011726     History of Changes
Other Study ID Numbers: 7437-CP-001
Study First Received: February 27, 2001
Last Updated: March 22, 2006
Health Authority: United States: Federal Government

Keywords provided by National Institute of Environmental Health Sciences (NIEHS):
Pregnancy
Lead Exposure
Lactation
Bone Mineralization
Maternal-Fetal Exchange

Additional relevant MeSH terms:
Lead Poisoning
Poisoning
Chemically-Induced Disorders

ClinicalTrials.gov processed this record on September 18, 2014